The Measures for Supervision and Inspection of Drug Clinical Trial Institutions (Trial) and Key Inspection Items and Judgment Principles for Supervision of Drug Clinical Trial Institutions (Trial) issued by the National Medical Products Administration shall come into force on March 1, 2024. To fully implement the regulatory requirements across all phases of clinical trials and raise researchers’ awareness of clinical trial quality management, our hospital held a special training themed Supervision Measures, Inspection Items and Judgment Principles for Drug Clinical Trial Institutions in the lecture hall on the 4th floor of the new building on February 27, 2024. Mo Yaxian, Party Secretary of the hospital and Director of the Drug Clinical Trial Institution, attended the training, with nearly 150 researchers from all departments participating.

At the training session, Secretary Mo Yaxian stressed the vital role of drug clinical trials in building a research-oriented hospital. She reminded researchers to pay close attention to every link and detail of trials and emphasized that quality is the lifeline of drug clinical trials. All researchers are required to conduct trials in a standardized, scientific and rigorous manner to elevate the overall capacity of clinical research and boost the high-quality development of the hospital.

Yang Hongying, Director of the GCP Office of Shenzhen People’s Hospital, interpreted institutional inspection clauses from the perspective of an experienced on-site inspector, sorting out 9 inspection modules and 62 individual items of institutional on-site checks one by one. Starting with the current regulatory landscape and legal provisions for drug trials, she analyzed high-risk links and key precautions in institutional management. She also highlighted that institutions should strengthen the administration of CRAs and CRCs, improve professional competence, reinforce trial quality control, and achieve better quality and efficiency.

Zhou Wenjing, Director of the GCP Office of the University of Hong Kong-Shenzhen Hospital, went through specialty-specific inspection items item by item, with special emphasis on key links such as informed consent for special populations, investigational drug management, data traceability and controlled paper documents throughout trial implementation.

This training further standardized the supervision and administration of the drug clinical trial institution, strengthened GCP awareness among all research staff, guided standardized and scientific trial practice, and effectively safeguarded the safety and legitimate rights and interests of trial subjects.